32 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
BonOs HV Genta, BonOs MV Genta, BonOs LV Genta
FDA 510(k)
FDA Class 2
·Orthopedic
DG Gel 8 Anti-AB
FDA UDI
DIAGNOSTIC GRIFOLS SA·08437014205107·The DG Gel 8 Anti-AB card is for the determinat...
CS 9300
FDA UDI
CARESTREAM HEALTH, INC.·60889975210124·CS 9300 230V R
Sportex
FDA UDI
Diversified Products, Inc.·00842894170526·
Dilator, Vascular, acc. Garrett 19cm 2.5mm
FDA UDI
Geister Medizintechnik GmbH·04057034046920·Dilator, Vascular, acc. Garrett
19cm 2...
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319744376·Kilner Skin Hook 5" (12.5cm), iris end
DHI Media & Controls
FDA UDI
DIAGNOSTIC HYBRIDS, INC.·30014613331186·MRC-5 GROWTH MEDIUM
Resolve® Ceramic
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K210152121·Resolve® Ceramic R022 UL 5-5 CS HK/MBT 4-5
Resolve® Ceramic
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K210152811·Resolve® Ceramic M022 UL 5-5 CS BC HK
Resolve® Ceramic
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K210152111·Resolve® Ceramic R022 UL 5-5 CS BC HK
Dilator, Vascular, acc. Garrett 19cm 2.5mm
FDA UDI
Geister Medizintechnik GmbH·04057034046937·Dilator, Vascular, acc. Garrett
19cm 2...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197544450·Jacobson Micro Scissors
210mm/...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197356770·Sauerbruch needle sterilising case
210x12...
INSTANT-VIEW BARBITUATE URINE DIP STRIP TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PROVOX LIFE STANDARD ADHESIVE OVAL
FDA Adverse Event
Injury
·ATOS MEDICAL AB·Product code KGX·January 4, 2024
Pharmaceutical Innovations
FDA UDI
PHARMACEUTICAL INNOVATIONS INC·00300362101255·PI SPRAY Ultrasound Cleaning Solution: 250 ml S...
NOVUM IQ
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 13, 2025
LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·September 17, 2025
P425 MANUAL BED
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNJ·October 20, 2008